Human Immunodeficiency VirusPhase 2NCT00051844
Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
A Phase 2 study testing Capravirine in people with Human Immunodeficiency Virus, run by Pfizer at 52 sites in 6 countries.
Trial summary
This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Capravirine
- How many people
- 179 participants
- Where
- 52 sitesin 6 countries
- Study dates
- Aug 2002to Nov 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years old
- HIV RNA level >1000 copies/mL at screening
- CD4 >50 cells/uL at screening
- Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen
- Patient has adequate hematology tests (absolute neutrophil count >1000/uL, Platelets>75,000uL, hemoglobin 9g/L)
- Patient has adequate renal function (serum creatinine of <1.5 upper limit of normal)
- Patient has adequate liver function (AST, ALT, and bilirubin < 2.5 upper limit of normal)
Who cannot join
- Previous use of protease inhibitors (except if patient has short duration of PI and was switched for tolerability reasons when viral load was <50 copies) This exception does not include Viracept
- Women who are pregnant or lactating
Trial locations and contacts
52 sites in 6 countries.
52 sites in 6 countries
United States30 sites
Pfizer Investigational Site
Akron, Ohio, 44304
Pfizer Investigational Site
Atlanta, Georgia, 30339-3915
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Beverly Hills, California, 90211
Pfizer Investigational Site
Brooklyn, New York, 11203
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Cincinnati, Ohio, 45267
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Fort Lauderdale, Florida, 33311
Pfizer Investigational Site
Galveston, Texas, 77555
Pfizer Investigational Site
Houston, Texas, 77009
Pfizer Investigational Site
Huntersville, North Carolina, 28078
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Jonesboro, Georgia, 30236
Pfizer Investigational Site
Long Beach, California, 90813
Pfizer Investigational Site
Miami, Florida, 33137
Pfizer Investigational Site
New York, New York, 10003
Pfizer Investigational Site
Newport Beach, California, 92663
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Portland, Oregon, 97209
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Safety Harbor, Florida, 34695
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
San Francisco, California, 94121
Pfizer Investigational Site
Stony Brook, New York, 11794
Pfizer Investigational Site
Tampa, Florida, 33602
Pfizer Investigational Site
Tucker, Georgia, 30084
Pfizer Investigational Site
West Hollywood, California, 90069
Pfizer Investigational Site
Wichita, Kansas, 67214
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157-1042
South Africa9 sites
Pfizer Investigational Site
Cape Town, 7405
Pfizer Investigational Site
Cape Town, 7925
Pfizer Investigational Site
Johannesburg, 02198
Pfizer Investigational Site
Johannesburg, 2008
Pfizer Investigational Site
Johannesburg, 2193
Pfizer Investigational Site
Pietermaritzburg, 3201
Pfizer Investigational Site
Port Elizabeth, 6001
Pfizer Investigational Site
Pretoria North, 0182
Pfizer Investigational Site
Soweto, 2013
France4 sites
Pfizer Investigational Site
Lyon, Cedex 02, 69288
Pfizer Investigational Site
Lyon, Cedex 3, 69437
Pfizer Investigational Site
Nantes, 44035
Pfizer Investigational Site
Paris, Cedex 10, 74575
Italy4 sites
Pfizer Investigational Site
Brescia, 25123
Pfizer Investigational Site
Milan, 20127
Pfizer Investigational Site
Milan, 20157
Pfizer Investigational Site
Roma, 00149
Spain4 sites
Pfizer Investigational Site
Barakaldo, Bilbao, Vizcaya, 48903
Pfizer Investigational Site
Barcelona, 08035
Pfizer Investigational Site
Bilbao, Vizcaya, 48903
Pfizer Investigational Site
Córdoba, 14004
About this study
Official title: A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen
This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Capravirine
- Keywords
- HIV, NNRTI Failure, HIV Infections
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapravirineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks
when compared to a 3-drug regimen without capravirine in patients who had experienced virologic failure while on a nonnucleoside reverse transcriptase inhibitor regimen.
Secondary outcomes (6)
The safety and tolerability of 2 doses of capravirine.
The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics
The relationship of HIV resistance (genotype and phenotype) to virologic response.
The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts
The population pharmacokinetics of capravirine and VIRACEPT
The pharmacokinetics of potential drug-drug interactions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2003 (estimated)
- Study startAug 2002
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051844
- Sponsor's protocol ID
- A4311002
- Status last verified
- May 2011
- First submitted
- 16 Jan 2003
- Last updated
- 10 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen
- ClinicalTrials.gov ID
- NCT00051844
- Acronym / sponsor ID
- A4311002
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, NNRTI Failure, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Nov 2004 (actual)
- First posted
- 20 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female at least 18 years old
- HIV RNA level >1000 copies/mL at screening
- CD4 >50 cells/uL at screening
- Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen
- Patient has adequate hematology tests (absolute neutrophil count >1000/uL, Platelets>75,000uL, hemoglobin 9g/L)
Key exclusion criteria (2 listed)
- Previous use of protease inhibitors (except if patient has short duration of PI and was switched for tolerability reasons when viral load was <50 copies) This exception does not include Viracept
- Women who are pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capravirine | Drug | – |
Primary outcome
The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks
when compared to a 3-drug regimen without capravirine in patients who had experienced virologic failure while on a nonnucleoside reverse transcriptase inhibitor regimen.
6 secondary outcomes
The safety and tolerability of 2 doses of capravirine.
The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics
The relationship of HIV resistance (genotype and phenotype) to virologic response.
The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts
The population pharmacokinetics of capravirine and VIRACEPT
The pharmacokinetics of potential drug-drug interactions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capravirine in people with Human Immunodeficiency Virus, run by Pfizer at 52 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, South Africa, France, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2011.